260112_CERTANIA_Alphalytik_webprofile
The experts for pharmaceutical analysis and stability testing

Alphalytik ensures the safety and efficacy of drugs through FDA-certified laboratory services

As a specialised laboratory for pharmaceutical analysis, we concentrate on the task of reliably ensuring the safety and efficacy of pharmaceuticals. Our focus is on stability testing, which we use to analyse the effects of temperature, light and humidity on pharmaceutical products. These tests accompany the entire life cycle of a drug and provide the basis for reliable shelf life and quality statements.

In addition, we develop and validate analytical methods, carry out stress and release tests and have particular expertise in the analysis of low-dose and hormonal preparations. This specialisation enables us to process even challenging issues precisely, reproducibly and in compliance with regulatory requirements.

As an FDA-approved laboratory, we work according to strict GMP specifications and rely on transparent processes, complete documentation and a high level of data integrity. We have been supporting many of our customers in the pharmaceutical industry for years because they rely on our reliability and the consistent quality of our results.

Our team combines analytical expertise with a practical understanding of regulatory requirements. This enables us to efficiently plan and implement both routine analyses and complex special tests. At the same time, we are constantly developing our methods in order to pick up on technical and regulatory developments at an early stage.

With this approach, we make an important contribution to ensuring that pharmaceutical products find their way to patients in a safe, stable and compliant manner.

Our focuses

Comprehensive analytical solutions for the pharmaceutical industry

We offer specialised analytical services such as stability tests, purity analyses and method validation. As an FDA-approved laboratory, we work according to strict GMP compliance and thus ensure the highest quality and safety standards – from development to the entire life cycle.

Advice on GMP and regulatory requirements

We provide support with GMP compliance, regulatory audits and employee training. With in-depth regulatory expertise, we help to reliably fulfil complex requirements and ensure that processes are always compliant – efficiently, clearly structured and practical.

Customised pharmaceutical testing services

Our portfolio includes microbiological safety tests, dissolution analyses and environmental stability studies. We ensure that products remain effective, pure and compliant under a wide range of conditions – for reliable results throughout the entire product life cycle.

Customised solutions for complex challenges

With over 30 years of experience, we develop solutions for challenging regulatory issues. We provide support for quality requirements, special tests and compliance challenges and combine precise analytics with a deep understanding of pharmaceutical processes.

Partner since 2024
location Berlin, Germany
Founded 1995

Get in touch with us

Alphalytik Pharmaservice GmbH
Grünberger Straße 44a
10245 Berlin 
Germany

Phone: +49 30 2938090 
E-mail: info@alphalytik.com

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